QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study 001

NCT ID: NCT05092438

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

595 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-08

Study Completion Date

2021-12-02

Brief Summary

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Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.

Detailed Description

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This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.

Conditions

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Meningitis/Encephalitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Residual specimens of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing
* Specimen that had not been centrifuged Adequate residual volume (≥400 μl)

Exclusion Criteria

* Specimens not fitting criteria outlined above
* CSF obtained from an external ventricular drain or shunt source
* Lack of clear subject identification or label on residual banked CSF specimen
* Obvious physical damage of banked residual specimen
* Repeat specimens from the same subject
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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QIAGEN Gaithersburg, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Johnson

Role: STUDY_DIRECTOR

QIAGEN Gaithersburg, Inc

Locations

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Qiagen

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SMF-DHF-18-0489-001

Identifier Type: -

Identifier Source: org_study_id

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